- Women with a positive pregnancy test at screening. Women of childbearing potential, who are pregnant or lactating, seeking pregnancy, or failing to take adequate contraceptive precautions, (e.g., an oral or injectable contraceptive, an approved hormonal implant or topical patch, an intrauterine device, abstinence. Should a female subject become sexually active, she must agree to use a double barrier method or barrier plus spermicide). A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a hysterectomy or surgical sterilization, e.g. bilateral tubal ligation, bilateral ovariectomy (oophorectomy).